A Modified Sinus Floor Elevation Technique - a Pilot Stud... | NCT02137824

Studies
A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

NCT02137824

Sponsor

Medical University of Vienna

Status

Recruiting

Last Update Posted

Mar 15, 2023Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Maxillary Sinus
Atrophy

Interventions

sinus floor elevation

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

May 12, 2014

First Submission Date that Met QC Criteria

May 13, 2014

First Posted Date

May 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 15, 2023Actual

Description Module

Brief Summary

The aim of the present study is to establish a modified minimally invasive surgical technique for sinus floor augmentation with a residual bone height of 3-6mm.

Hypothesis: The investigators expect that the present surgical technique allows to achieve an adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further the modification of the technique enables a reduced patient stress level.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Label	Type	Description	Intervention Names
sinus floor elevation	Experimental		Procedure: sinus floor elevation

Name	Type	Description	Arm Group Labels	Other Names
sinus floor elevation	Procedure		sinus floor elevation

Measure	Description	Time Frame
Height of augmentation		after 4-5months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

residual bone height of 3-6mm
residual bone width of >4mm

Exclusion Criteria:

not treated periodontal disease
smoker (>5cig/day)
acute or chronic sinusitis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristina Bertl, PD, DMD, MSc	Contact			kristina.bertl@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bernhard Gottlieb School of Dentistry, Medical University of Vienna	Recruiting	Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D001284	Atrophy

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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